Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 3, 2024 | The Distal Access Catheter is a single-lumen, braided shaft, variable stiffne... | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access... | Class II | Stryker Neurovascular |
| Apr 2, 2024 | Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStai... | There is the potential for the front plexiglass door of the automated slide processing system to ... | Class II | Agilent Technologies |
| Apr 2, 2024 | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) | A packaging seal gap could impact the sterility of the product. | Class II | Andover Healthcare Inc. |
| Apr 2, 2024 | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US | Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured befor... | Class II | Fisher & Paykel Healthcare, Ltd. |
| Apr 1, 2024 | EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 | Devices may contain elevated levels of bacterial endotoxin. | Class II | Cook Medical Incorporated |
| Apr 1, 2024 | OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 11... | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alar... | Class I | Philips Respironics, Inc. |
| Apr 1, 2024 | LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Applicat... | Laser surgical instruments have no specific evidence of a validated reprocessing method, therefor... | Class II | Karl Storz Endoscopy |
| Apr 1, 2024 | EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 | Devices may contain elevated levels of bacterial endotoxin. | Class II | Cook Medical Incorporated |
| Mar 29, 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, s... | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), ... | Class II | Stryker Leibinger GmbH & Co. KG |
| Mar 29, 2024 | The Oncology Essentials Package of the Spectral CT imaging system. | Potential for third party oncology marking laser to be reflected off the gantry cover surface, wh... | Class II | Philips North America Llc |
| Mar 29, 2024 | LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 29, 2024 | LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A ... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 28, 2024 | RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | HORIBA custom configured fluorescence instrument, modular Fluorolog-QM | HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configur... | Class II | Horiba Instruments Incorporated |
| Mar 28, 2024 | RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiati... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Class II | Medtronic Neuromodulation |
| Mar 28, 2024 | RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning Sys... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Pl... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 7.0.0.19. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 15.0.0.430. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of ... | Out of specification violation of devices that results in a gap existing within the fixture that ... | Class II | Zimmer, Inc. |
| Mar 28, 2024 | RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy ... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System. | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Plannin... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2024 | RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment ... | Potential for reported SSD to be too high. | Class II | RAYSEARCH LABORATORIES AB |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475 | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5... | According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser prod... | Class II | Newport Corp |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 26, 2024 | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Use... | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either... | Class I | Medtronic Navigation, Inc. |
| Mar 26, 2024 | Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following ... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN,... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbe... | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| Mar 26, 2024 | BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and ... | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| Mar 26, 2024 | Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed... | Baxter received reports of an issue related to the construction of the power cord not meeting the... | Class II | Baxter Healthcare Corporation |
| Mar 26, 2024 | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N | Complaints have been received with allegations of Incorrect Needle Curvature. | Class II | SURGICAL SPECIALTIES |
| Mar 26, 2024 | BiPAP V30 Auto Ventilator, Part Number 1111178 | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| Mar 25, 2024 | RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to ... | Class I | SonarMed Inc |
| Mar 23, 2024 | 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/7... | Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not select... | Class II | Philips Ultrasound, Inc. |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYN... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DY... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF C... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.